BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS GLU SLIDES

    MDR report key: 1972903 · Received January 28, 2011

    Report

    Report Number
    1319809-2011-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 28, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS GLU RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS AND MULTIPLE PATIENT SAMPLES ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THE RESULTS IN QUESTION WERE CAUSED BY AN ANALYZER MALFUNCTION. THE HIGHER THAN EXPECTED VITROS GLU RESULTS WERE ISOLATED TO A SINGLE SLIDE CARTRIDGE, AND THE EVENT IS CONSISTENT WITH A COMPROMISED FOIL WRAPPER. AN ALTERNATE VITROS GLU SLIDE CARTRIDGE FROM THE SAME LOT RESOLVED THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE ROOT CAUSE IS MOST LIKELY DUE TO USER ERROR IN THE IMPROPER USE OF A SHARP INSTRUMENT WHEN OPENING THE PRODUCT PACKAGING.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED HIGHER THAN EXPECTED VITROS GLU RESULTS FROM QUALITY CONTROL FLUIDS AND MULTIPLE PATIENT SAMPLES WHEN USING A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HIGHER THAN EXPECTED VITROS GLU PATIENT RESULTS WERE INITIALLY REPORTED OUT OF THE LABORATORY. ONCE THE ISSUE WAS IDENTIFIED, CORRECTED REPORTS WERE ISSUED FOR ALL AFFECTED PATIENT SAMPLES. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS GLU SLIDES IN-VITRO DIAGNOSTIC CGA ORTHO-CLINICAL DIAGNOSTICS 0021-0788-2110

    Patients

    Seq Age Sex Outcome Treatment
    1